NCT00946907

Brief Summary

Treatment of pericarditis largely remains empirical due to the relative lack of randomized controlled trials. Nevertheless, some recommendations have been formulated to guide management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages is the mainstay of treatment. Optimal length of treatment is not established. PERICARDITE is a French multicentric placebo controlled double blind randomized trial assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non inferiority trial. Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction, autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis, neoplastic disease). Primary endpoint is: 30 days recovery defined as the normalization of all clinical and paraclinical initial abnormalities. Secondary endpoint is: 6-month recurrence.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 21, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

July 24, 2009

Last Update Submit

December 20, 2011

Conditions

Pericarditis

Keywords

acute pericarditistreatmentrecurrence

Outcome Measures

Primary Outcomes (1)

  • recovery

    30 days

Study Arms (2)

aspirin

ACTIVE COMPARATOR
Drug: Aspirin

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

AspirinDRUG

3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days

aspirin
placeboDRUG

3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18
  • first episode of acute pericarditis
  • chest pain lasting less than 24 hours

You may not qualify if:

  • contraindication to aspirin
  • previous history of atypical chest pain
  • previous history of connective tissue disease, tuberculosis, recent MI, auto immune disease, neoplastic disease, thoracic trauma, previous thoracic surgery, antiplatelet routine treatment, anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU de Brest

Brest, 29 609, France

Location

HIA Clermont Tonnerre

Brest, 29200, France

Location

CHG Carhaix

Carhaix-Plouguer, 29270, France

Location

CHG Douarnenez

Douarnenez, 29171, France

Location

CH Lannion

Lannion, 22300, France

Location

CHG Lorient

Lorient, 56322, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

CH Morlaix

Morlaix, 29672, France

Location

Hôpital Claude Bernard APHP

Paris, 75877, France

Location

Centre Hospitalier Intercommunal de Cornouaille

Quimper, 29107, France

Location

CHG Saint-Brieuc

Saint-Brieuc, 22023, France

Location

HIA Sainte-Anne

Toulon, 83800, France

Location

Related Publications (2)

  • Maisch B, Seferovic PM, Ristic AD, Erbel R, Rienmuller R, Adler Y, Tomkowski WZ, Thiene G, Yacoub MH; Grupo de Trabajo para el Diagnostico y Tratamiento de las Enfermedades del Pericardio de la Sociedad Europea de Cardiologia. [Guidelines on the diagnosis and management of pericardial diseases. Executive summary]. Rev Esp Cardiol. 2004 Nov;57(11):1090-114. doi: 10.1016/s0300-8932(04)77245-0. No abstract available. Spanish.

    PMID: 15544758BACKGROUND

  • Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.

    PMID: 16186437BACKGROUND

MeSH Terms

Conditions

PericarditisRecurrence

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • jean-christophe cornily, md

    FESC, Fellow of the french society of cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 21, 2011

Record last verified: 2011-12

Locations

FR(12)